Iliotibial Band SyndromeNCT05973708
Comparative Effects of Clamshells and Frog Pump Exercises
A study testing Clamshell Exercise and Frog pump exercise in people with Iliotibial Band Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial summary
Iliotibial band syndrome is where a tendon called iliotibial band gets irritated or swollen from rubbing against hip or knee when it gets too tensed. Iliotibial band (ITB) syndrome (ITBS) is the most common cause of lateral knee pain among athletes who are involved in sports that require continuous running or… Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Iliotibial Band Syndrome
- What is being tested?
- Clamshell Exercise and Frog pump exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Oct 2023to 10 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- • Age (18-30yrs)
- Gender (Males)
- Positive Ober's test
- Positive Noble's compression test
- Suffering pain from past 3 months
- Running approximately 5km/week
Who cannot join
- • Osteoporosis
- Previous knee trauma/surgery
- Patellofemoral joint pain
- Popliteus tendinitis
- Lateral meniscal injure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effects of Clamshells and Frog Pump Exercises on Gluteus Medius Strengthening and Lower Extremity Function in Runners With Iliotibial Band Syndrome
Iliotibial band syndrome is where a tendon called iliotibial band gets irritated or swollen from rubbing against hip or knee when it gets too tensed. Iliotibial band (ITB) syndrome (ITBS) is the most common cause of lateral knee pain among athletes who are involved in sports that require continuous running or repetitive knee flexion and extension. The incidence ranges from 1.6% to 12% in runners. The aim of the study is to compare the effects of clamshells and frog pump exercises on gluteus medius strengthening and lower extremity function in runners with iliotibial band syndrome.
Read the detailed description
This study will be a randomized clinical trial and will be conducted in Pakistan Sports Board Lahore. Non-probability convenient sampling will be used to collect the data. Sample size of 32 subjects with age group between 18-30 years (males) will be taken. Data will be collected from the runners with tight ITB, by using tools LEFS, HOS-SS, and Hand held dynamometer. An informed consent will be taken. A total of 26 subjects will be selected by following inclusion and exclusion criteria and will equally divided in to two groups by random number generator table. Both the Groups will continue the conventional training with Group A will receive clamshell Exercise, and Group B will receive frog pump exercise in their respective training programs. Outcome measures will be measured at baseline and after 2 weeks. Data analysis will be done by SPSS version 25.
- Conditions
- Iliotibial Band Syndrome
- Being tested
- Clamshell Exercise, Frog pump exercise
- Keywords
- gluteus medius, pain, iliotibial band syndrome, strength
- Medical subject headings
- Iliotibial Band Syndrome, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clamshell ExerciseOther
Clamshell Exercise: The clamshell exercise keeps the hips moving, it strengthens both the gluteus medius AND gluteus maximus. The gluteus medius is the main abductor (movement away from the midline of the body) and external rotator of the hip.
Frog pump exerciseOther
Frog pump exercise: The frog hip thrust mainly targets the gluteal muscles responsible for thigh extension and abduction. The exercise also works the hamstrings on the back of the thighs which helps in hip extension.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Clamshell Exercise | Active comparator | Group B will be given frog pumps exercises in their regular training program.
These exercises are given as:
* In (0-2) week ,2 sets 10 repetitions
* In (2-4)week, 3 sets of 10 repetitions
* In (4-6)week, 3 sets of 15 repetitions Receives: Other: Clamshell Exercise |
| Group B: Frog Pump Exercise | Active comparator | Group B will be given frog pumps exercises in their regular training program.
These exercises are given as:
* In (0-2) week ,2 sets 10 repetitions
* In (2-4)week, 3 sets of 10 repetitions
* In (4-6)week, 3 sets of 15 repetitions Receives: Other: Frog pump exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Manual Muscle Testing (MMT)
For measuring the strength of Hip muscles, Manual Muscle Testing (MMT) is used.
Manual Muscle Testing (MMT) is a standardised set of assessments that measure muscle strength and function against specific criteria and is commonly used in clinical practice by physiotherapists.
Grading Scale Range: 0 to 5 0 None No visible or palpable contraction
- Trace Visible or palpable contraction with no motion
- Poor Full ROM gravity eliminated
- Fair Full ROM against gravity
- Good Full ROM against gravity, moderate resistance
- Normal Full ROM against gravity, maximum resistance
Measured: upto 6th weeks
Hip Outcome Score (HOS)
The hip outcome score (HOS) is a questionnaire used to measure the function of the Hip.
The HOS is a patient-completed measure that consists of an "Activities of Daily Living" subscale (17 scored items) and a "Sports" subscale (9 scored items) in which the response options are presented as 5-point Likert scales (Scores 0-4).
Measured: upto 6th weeks
Lower Extremity Functional Scale (LEFS)
The lower extremity functional scale (LEFS) measures the function and disability of the lower extremity.
LEFS is a well-known and validated instrument for the measurement of lower extremity function. The LEFS was developed in a group of patients with various musculoskeletal disorders.
The LEFS rating scale categories are: (1) "extreme difficulty or unable to perform," (2) "quite a bit of difficulty," (3) "moderate difficulty," (4) "a little bit of difficulty," and (5) "no difficulty." LEFS score = SUM (points for all 20 activities) Interpretation: Minimum score: 0 Maximum score: 80 The lower the score the greater the disability.
Measured: upto 6th weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start5 Oct 2023
- Primary completion8 Mar 2024
- Study completion10 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Iliotibial Band SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samrood Akram, Mphil, Principal investigator, Riphah International University,Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05973708
- Sponsor's protocol ID
- REC/RCR & AHS/23/0411
- Status last verified
- Apr 2024
- First submitted
- 27 Jun 2023
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Friede MC, Innerhofer G, Fink C, Alegre LM, Csapo R. Conservative treatment of iliotibial band syndrome in runners: Are we targeting the right goals? Phys Ther Sport. 2022 Mar;54:44-52. doi: 10.1016/j.ptsp.2021.12.006. Epub 2021 Dec 27.
PubMed 35007886Baker RL, Souza RB, Fredericson M. Iliotibial band syndrome: soft tissue and biomechanical factors in evaluation and treatment. PM R. 2011 Jun;3(6):550-61. doi: 10.1016/j.pmrj.2011.01.002.
PubMed 21665168Khaund R, Flynn SH. Iliotibial band syndrome: a common source of knee pain. Am Fam Physician. 2005 Apr 15;71(8):1545-50.
PubMed 15864895Fredericson M, Guillet M, Debenedictis L. Innovative solutions for iliotibial band syndrome. Phys Sportsmed. 2000 Feb;28(2):53-68. doi: 10.3810/psm.2000.02.693.
PubMed 20086621McKay J, Maffulli N, Aicale R, Taunton J. Iliotibial band syndrome rehabilitation in female runners: a pilot randomized study. J Orthop Surg Res. 2020 May 24;15(1):188. doi: 10.1186/s13018-020-01713-7.
PubMed 32448384Fredericson M, Wolf C. Iliotibial band syndrome in runners: innovations in treatment. Sports Med. 2005;35(5):451-9. doi: 10.2165/00007256-200535050-00006.
PubMed 15896092
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Clamshells and Frog Pump Exercises on Gluteus Medius Strengthening and Lower Extremity Function in Runners With Iliotibial Band Syndrome
- ClinicalTrials.gov ID
- NCT05973708
- Acronym / sponsor ID
- REC/RCR & AHS/23/0411
- Conditions
- Iliotibial Band Syndrome
- Keywords
- gluteus medius, pain, iliotibial band syndrome, strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 5 Oct 2023 (actual)
- Primary completion
- 8 Mar 2024 (actual)
- Study completion
- 10 Mar 2024 (actual)
- First posted
- 3 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Iliotibial band syndrome is where a tendon called iliotibial band gets irritated or swollen from rubbing against hip or knee when it gets too tensed. Iliotibial band (ITB) syndrome (ITBS) is the most common cause of lateral knee pain among athletes who are involved in sports that require continuous running or repetitive knee flexion and extension. The incidence ranges from 1.6% to 12% in runners. The aim of the study is to compare the effects of clamshells and frog pump exercises on gluteus medius strengthening and lower extremity function in runners with iliotibial band syndrome.
Detailed description
This study will be a randomized clinical trial and will be conducted in Pakistan Sports Board Lahore. Non-probability convenient sampling will be used to collect the data. Sample size of 32 subjects with age group between 18-30 years (males) will be taken. Data will be collected from the runners with tight ITB, by using tools LEFS, HOS-SS, and Hand held dynamometer. An informed consent will be taken. A total of 26 subjects will be selected by following inclusion and exclusion criteria and will equally divided in to two groups by random number generator table. Both the Groups will continue the conventional training with Group A will receive clamshell Exercise, and Group B will receive frog pump exercise in their respective training programs. Outcome measures will be measured at baseline and after 2 weeks. Data analysis will be done by SPSS version 25.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Clamshell Exercise | Active comparator | Other: Clamshell ExerciseGroup B will be given frog pumps exercises in their regular training program. These exercises are given as: * In (0-2) week ,2 sets 10 repetitions * In (2-4)week, 3 sets of 10 repetitions * In (4-6)week, 3 sets of 15 repetitions |
| Group B: Frog Pump Exercise | Active comparator | Other: Frog pump exerciseGroup B will be given frog pumps exercises in their regular training program. These exercises are given as: * In (0-2) week ,2 sets 10 repetitions * In (2-4)week, 3 sets of 10 repetitions * In (4-6)week, 3 sets of 15 repetitions |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- • Age (18-30yrs)
Key exclusion criteria (5 listed)
- • Osteoporosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clamshell ExerciseClamshell Exercise: The clamshell exercise keeps the hips moving, it strengthens both the gluteus medius AND gluteus maximus. The gluteus medius is the main abductor (movement away from the midline of the body) and external rotator of the hip. | Other | Group A: Clamshell Exercise |
| Frog pump exerciseFrog pump exercise: The frog hip thrust mainly targets the gluteal muscles responsible for thigh extension and abduction. The exercise also works the hamstrings on the back of the thighs which helps in hip extension. | Other | Group B: Frog Pump Exercise |
Primary outcome
Manual Muscle Testing (MMT)
Time frame: upto 6th weeks
For measuring the strength of Hip muscles, Manual Muscle Testing (MMT) is used. Manual Muscle Testing (MMT) is a standardised set of assessments that measure muscle strength and function against specific criteria and is commonly used in clinical practice by physiotherapists. Grading Scale Range: 0 to 5 0 None No visible or palpable contraction 1. Trace Visible or palpable contraction with no motion 2. Poor Full ROM gravity eliminated 3. Fair Full ROM against gravity 4. Good Full ROM against gravity, moderate resistance 5. Normal Full ROM against gravity, maximum resistance
Hip Outcome Score (HOS)
Time frame: upto 6th weeks
The hip outcome score (HOS) is a questionnaire used to measure the function of the Hip. The HOS is a patient-completed measure that consists of an "Activities of Daily Living" subscale (17 scored items) and a "Sports" subscale (9 scored items) in which the response options are presented as 5-point Likert scales (Scores 0-4).
Lower Extremity Functional Scale (LEFS)
Time frame: upto 6th weeks
The lower extremity functional scale (LEFS) measures the function and disability of the lower extremity. LEFS is a well-known and validated instrument for the measurement of lower extremity function. The LEFS was developed in a group of patients with various musculoskeletal disorders. The LEFS rating scale categories are: (1) "extreme difficulty or unable to perform," (2) "quite a bit of difficulty," (3) "moderate difficulty," (4) "a little bit of difficulty," and (5) "no difficulty." LEFS score = SUM (points for all 20 activities) Interpretation: Minimum score: 0 Maximum score: 80 The lower the score the greater the disability.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Background: PubMed 35007886Friede MC, Innerhofer G, Fink C, Alegre LM, Csapo R. Conservative treatment of iliotibial band syndrome in runners: Are we targeting the right goals? Phys Ther Sport. 2022 Mar;54:44-52. doi: 10.1016/j.ptsp.2021.12.006. Epub 2021 Dec 27.
- Background: PubMed 21665168Baker RL, Souza RB, Fredericson M. Iliotibial band syndrome: soft tissue and biomechanical factors in evaluation and treatment. PM R. 2011 Jun;3(6):550-61. doi: 10.1016/j.pmrj.2011.01.002.
- Background: PubMed 15864895Khaund R, Flynn SH. Iliotibial band syndrome: a common source of knee pain. Am Fam Physician. 2005 Apr 15;71(8):1545-50.
- Background: PubMed 20086621Fredericson M, Guillet M, Debenedictis L. Innovative solutions for iliotibial band syndrome. Phys Sportsmed. 2000 Feb;28(2):53-68. doi: 10.3810/psm.2000.02.693.
- Background: PubMed 32448384McKay J, Maffulli N, Aicale R, Taunton J. Iliotibial band syndrome rehabilitation in female runners: a pilot randomized study. J Orthop Surg Res. 2020 May 24;15(1):188. doi: 10.1186/s13018-020-01713-7.
- Background: PubMed 15896092Fredericson M, Wolf C. Iliotibial band syndrome in runners: innovations in treatment. Sports Med. 2005;35(5):451-9. doi: 10.2165/00007256-200535050-00006.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samrood Akram, Mphil principal investigator
Riphah International University,Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clamshell Exercise and Frog pump exercise in people with Iliotibial Band Syndrome, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Manual Muscle Testing (MMT) (time frame: upto 6th weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05973708, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2024.